Stent range transducers
A system for delivering and positioning a stent within a bifurcated body lumen includes a stent delivery system including a catheter, an expansion device, and an ultrasound transducer. The ultrasound transducer is configured for transmitting and receiving signals and for imaging of a body lumen so as to locate an ostium of a branch vessel and facilitate alignment of the stent side hole with the ostium.
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This application is a Continuation of U.S. patent application Ser. No. 09/669,060, filed Sep. 22, 2000, now U.S. Pat. No. 6,689,156. This application claims priority to U.S. application Ser. No. 09/669,060 to the extent appropriate under the law. U.S. patent application Ser. No. 09/669,060 claims priority to U.S. Provisional Application No. 60/155,611 filed on Sep. 23, 1999, to the extent appropriate under the law. The complete disclosures of U.S. patent application Ser. No. 09/669,060 and U.S. provisional application Ser. No. 09/669,060 are incorporated herein by reference.
CROSS-REFERENCES TO RELATED APPLICATIONSThis application is related to U.S. patent application Ser. No. 09/668,687, entitled “Differentially Expanding Stent and Methods of Use”; and U.S. patent application Ser. No. 09/668,832, entitled, “Bifurcation Stent Systems and Methods,” the complete disclosures of which are incorporated herein by reference.
BACKGROUND OF THE INVENTIONA type of endoprosthesis device, commonly referred to as a stent, may be placed or implanted within a vein, artery or other hollow body organ or lumen for treating occlusions, stenoses, or aneurysms of a vessel by reinforcing the wall of the vessel or by expanding the vessel. Stents have been used to treat dissections in blood vessel walls caused by balloon angioplasty of the coronary arteries as well as peripheral arteries and to improve angioplasty results by preventing elastic recoil and remodeling of the vessel wall. Two randomized multicenter trials have recently shown a lower restenosis rate in stent treated coronary arteries compared with balloon angioplasty alone (Serruys, P W et al., New England Journal of Medicine 331: 489-495 (1994) and Fischman, D L et al. New England Journal of Medicine 331:496-501 (1994)). Stents have been successfully implanted in the urinary tract, the bile duct, the esophagus and the tracheo-bronchial tree to reinforce those body organs, as well as implanted into the neurovascular, peripheral vascular, coronary, cardiac, and renal systems, among others. The term “stent” as used in this Application is a device which is intraluminally implanted within bodily vessels to reinforce collapsing, dissected, partially occluded, weakened, diseased or abnormally dilated or small segments of a vessel wall.
One of the drawbacks of conventional stents is that they are difficult to position. In general, positioning a stent involves moving the stent to the desired position and then maintaining the position while the stent is deployed. Accurate positioning is critical to proper operation of the stent. For example, the use of such stents to treat diseased vessels at or near a bifurcation (branch point) of a vessel requires very accurate positioning otherwise, there is a potential for compromising the degree of patency of the main vessel and/or its branches, or the bifurcation point. Compromising the bifurcation point limits the ability to insert a branch stent into the side branch if the result of treatment of the main vessel is suboptimal. Suboptimal results may occur as a result of several mechanisms, such as displacing diseased tissue, plaque shifting, vessel spasm, dissection with or without intimal flaps, thrombosis, and embolism.
In light of the foregoing, it would be desirable to provide methods, apparatus and/or systems to increase stent positioning accuracy, particularly when used with bifurcated body lumens.
SUMMARY OF THE INVENTIONThe present invention provides exemplary apparatus, systems and methods for accurately delivering and positioning a stent within a body lumen, particularly within a bifurcated body lumen. In one embodiment, a stent delivery system according to the present invention includes a catheter comprising a catheter body having a distal end, a proximal end, a longitudinal axis and a lumen. An expansion device, which in one embodiment is a balloon, is disposed near the catheter body distal end, and a stent having a side hole is disposed over the expansion device. An ultrasound transducer is disposed near the catheter body distal end and positioned for transmitting and receiving ultrasound signals through the side hole. In this manner, an intravascular ultrasound catheter and system is used to help properly position the stent, and properly align the stent side hole with a branch vessel.
The ultrasound transducer is disposed inside the expansion device, or between the expansion device and stent in alternative embodiments. Preferably, the ultrasound transducer is adapted to be axially translated along the longitudinal axis and/or rotated relative to the longitudinal axis. In this manner, the ultrasound transducer may be used to image surrounding fluids and tissue to assure proper stent alignment.
In some embodiments, the stent delivery system further includes a transducer housing to which the transducer is coupled. The housing has distal and proximal ends, with a passageway passing therethrough. The passageway has a guidewire partially disposed therein in one embodiment. The housing proximal end is coupled to a drive cable, which in one embodiment is adapted to rotate the housing relative to the catheter distal end. A controller may be included, coupled to the transducer, to facilitate system operation.
The present invention further provides methods of positioning a stent having a side opening. In one embodiment, the method includes providing a stent delivery system ostensibly as described herein, positioning the stent delivery system in a body lumen, imaging the body lumen with the transducer to locate an ostium of a branch vessel, and aligning the stent side hole with the ostium. In this manner, the use of ultrasound imaging facilitates proper stent side hole alignment with the branch vessel.
In one embodiment, the ultrasound transducer is adapted to rotate relative to the longitudinal axis. The imaging further includes rotating the transducer to image a cross section of the body lumen. Similarly, in one embodiment, aligning the stent side hole includes axially translating the stent along the longitudinal axis and/or rotating the stent about the longitudinal axis. In some embodiments, a body lumen guidewire is introduced, and the catheter is advanced over the guidewire to be near the branch vessel.
In one embodiment, the stent delivery system is conveniently part of a kit, which includes instructions for use setting forth a method for positioning the stent in a bifurcated body lumen so that the side hole is substantially aligned with an ostium of a branch vessel.
Other objects, features and advantages of the present invention will become more fully apparent from the following detailed description, the appended claims and the accompanying drawings.
Turning now to
Turning now to
Transducer housing 24 is adapted to be translated axially along a longitudinal axis 200. In one embodiment, the axial translation of transducer housing 24 is made relative to stent 10. Alternatively, balloon 20 and transducer housing 24 are disposed such that they move in parallel, maintaining the proper configuration of transducer 22 with respect to side hole 12.
Drive cable 44 defines guidewire lumen 38 into which transducer wires 36 are disposed. Inner member 34 maintains transducer wires 36 within wire lumen 38. Further, inner member 34 defines passageway 40 through which guidewire 18 may be disposed. In an alternative embodiment, guidewire 18 passes through balloon lumen 30, adjacent to drive cable 44 or sheath 46.
Turning now to
Images depicted in
As shown, system 100 includes a guidewire 190 over which a balloon 170 and a stent 160 are disposed. A control circuitry, as shown in
As previously described, the time delay of signals received from echoes off the branch vessel are greater than the time delay from signals received off of the main vessel walls. In one embodiment, receiver filter 350 may be used to indicate to a user of system 100 that side hole 12 is aligned, or not aligned, with branch vessel 16. For example, one or more indicator lights 380 may be used to indicate side hole alignment (green) or non-alignment (red). In some embodiments, circuitry 300 does not produce a visual image of the body lumen. Instead, the signals received from transducer 330 are used to indicate sidehole to branch vessel alignment. A power supply 370 facilitates operation of the individual electrical components.
As shown in
The invention has now been described in detail for purposes of clarity of understanding. However, it will be appreciated that certain changes and modifications may be practiced within the scope of the appended claims. For example, while transducer 22 is generally described as coupled to a drive cable 44 facilitating transducer rotation, transducer 22 also may be fixed relative to stent 10. In such an embodiment, transducer 22 would comprise a side-looking transducer facing side hole 12. In this manner, transducer 22 would be aligned with side hole 12 to facilitate side hole 12 alignment with branch vessel 16. Such a configuration would produce images similar to that shown in
Claims
1. A stent delivery system, said system comprising:
- a catheter comprising a catheter body having a distal end, a proximal end and a lumen;
- a balloon disposed near said catheter body distal end;
- a stent having a wall comprising struts and connectors forming multiple passageways and further comprising a side hole, said stent disposed over said balloon;
- an ultrasound transducer housing having a distal end, a proximal end, and a passage extending through a central portion of said housing between said distal and proximal ends, said housing having a transducer coupled thereto; and
- a positioning guidewire at least partially disposed in said catheter lumen, said guidewire passing through said transducer housing passage.
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Type: Grant
Filed: Jan 16, 2004
Date of Patent: Sep 8, 2009
Patent Publication Number: 20040148006
Assignee: Boston Scientific Scimed, Inc. (Maple Grove, MN)
Inventors: Charles J. Davidson (Winnetka, IL), Gil M. Vardi (Chesterfield, MO), Eric Williams (Evanston, IL), Stephen Kao (Mountain View, CA), Niyazi U. Behyan (Santa Clara, CA)
Primary Examiner: William H. Matthews
Attorney: Crompton Seager & Tufte LLC
Application Number: 10/758,020
International Classification: A61F 2/06 (20060101);